510(k) · Cleared
ClearedModified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocare, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Jun 6, 2002 as substantially equivalent to K011040 (Endocare, Inc., 2001) after a 69-day review. Its family tree reaches back 1 generation to 2001. 43 later devices descend from it.
- Decided
- Jun 6, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011040 (2001). 43 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011040 Cryocare Cardiac Surgical SystemEndocare, Inc. · 2001
- This deviceK021010 Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 2 generations on · 16 of its ownK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 14 of its ownK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · cites it directly42descendants
- K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · cites it directly22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 2 generations on18descendants
- K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · 2 generations on16descendants
- K111042Atricure Cryo ModuleAtriCure, Inc. · 2011 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011040 | Cryocare Cardiac Surgical System | Endocare, Inc. | 2001 | — |
| 0 (this device) | K021010 | Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE | Endocare, Inc. | 2002 | — |
| +1 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| +1 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| +2 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +2 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| +3 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCL device
- #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011040 | Cryocare Cardiac Surgical System | 2001 |
What descends from it? (43)
See all 433 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console | 2004 | 42 |
| K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical… | 2006 | 22 |
| K062140 | Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1 | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OCL devicesOCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCL
85in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCL
46in 2025
MAUDE reports naming product code OCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 139 | 0 | 0 |
| 2008 | 5 | 81 | 1 | 0 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 2 | — | 2 | 23 |
| 2011 | 2 | — | 0 | 21 |
| 2012 | 6 | 75 | 0 | 21 |
| 2013 | 2 | — | 1 | 13 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 1 | 76 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 2 | — | 0 | 61 |
| 2019 | 6 | 85 | 4 | 49 |
| 2020 | 1 | — | 4 | 37 |
| 2021 | 2 | — | 1 | 63 |
| 2022 | 2 | — | 0 | 59 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021010 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021010
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026